U.S. patent application number 13/396605 was filed with the patent office on 2012-08-16 for nocipoint therapy: threshold-gated electrical neuro-immuno-stimulation procedure.
Invention is credited to Charles C. Koo.
Application Number | 20120209348 13/396605 |
Document ID | / |
Family ID | 46637492 |
Filed Date | 2012-08-16 |
United States Patent
Application |
20120209348 |
Kind Code |
A1 |
Koo; Charles C. |
August 16, 2012 |
Nocipoint Therapy: Threshold-gated Electrical
Neuro-Immuno-Stimulation Procedure
Abstract
A method of reducing pain includes first identifying a muscle;
then identify a related pair of Nocipoints on the identified
muscle; and applying electrical stimulation to the pair If
required, the method may further comprise identifying additional
pairs of Nocipoints and applying electrical stimulation to them.
The stimulation should be from about 1.5 to 3.5 minutes.
Inventors: |
Koo; Charles C.; (Palo Alto,
CA) |
Family ID: |
46637492 |
Appl. No.: |
13/396605 |
Filed: |
February 15, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61443258 |
Feb 16, 2011 |
|
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Current U.S.
Class: |
607/46 |
Current CPC
Class: |
A61N 1/36034 20170801;
A61N 1/36021 20130101 |
Class at
Publication: |
607/46 |
International
Class: |
A61N 1/36 20060101
A61N001/36 |
Claims
1. A method, comprising: identifying a muscle that causes pain;
identifying a related Nocipoint on one side of the identified
muscle; identifying a second related Nocipoint on an other side of
the identified muscle; attaching electrodes to the pair of
Nocipoints; apply electrical stimulation to the pair of Nocipoints;
and, if necessary, finding a next muscle and its corresponding pair
of Nocipoints that causes pain for electrical stimulation.
2. The method of claim 1, wherein the electrical stimulation for
each pair of Nocipoints ranges from about 1.5 minutes to about 3.5
minutes.
3. The method of claim 1, wherein the electrical stimulation for
each pair of Nocipoints has a firing minimum threshold of about 10
mV measured subcutaneously at the nerve.
4. The method of claim 1, wherein the electrical stimulation for
each pair of Nocipoints has an maximum action potential of about 60
mV measured subcutaneously at the nerve.
5. The method of claim 1, wherein the electrical stimulation for
each pair of Nocipoints enables a C-fiber nerve response.
6. The method of claim 1, wherein the electrical stimulation has a
square wave or a sine wave pattern.
7. The method of claim 6, wherein a pulse frequency of the wave is
about 20 to about 80 Hz.
8. The method of claim 7, wherein an operating range of pulse
amplitude of the stimulation is about 70 to about 130 V.
8. The method of claim 6, wherein a pulse frequency of the wave is
about 8-20 Hz.
9. The method of claim 8, wherein an operating range of pulse
amplitude of the wave is about 130 to about 170 V.
10. The method of claim 6, wherein the electrical stimulation has a
sine wave pattern.
11. The method of claim 6, wherein a pulse frequency of the square
wave is about 9 Hz.
12. The method of claim 11, wherein an operating range of pulse
amplitude of the square wave is about 130 to about 170 V.
Description
PRIORITY CLAIM This application claims priority to and incorporates
by reference U.S. Patent Application No. 61/443,258 filed Feb. 16,
2011.
FIELD OF THE INVENTION
[0001] At least one embodiment of the present invention pertains to
medical procedures and more particularly, but not exclusively, to
reducing pain through electrical stimulation of Nocipoints.
BACKGROUND
[0002] Chronic skeletal-muscular pain costs the US $200+B a year
and increasing in terms of loss of time and medical expenses
according to the 2011 CDC report. However, they are merely the
manifestation of the underlying causes--skeletal-muscular injuries
or pinched nerves.
[0003] Skeletal-muscular injuries from car accidents, sports,
exercises, sudden movement, wrong postures or sometime unknown
reasons are the major cause of such pain. Standard self-care
process includes cold/heat pads and good rest for a period of time.
In many cases, especially in acute cases, the body recovers; the
muscle injury heals, and the pain disappears. Unfortunately, many
people, 112 million in the US, get stuck with chronic pain,
according to the CDC report.
[0004] Pinched nerves at spinal cord cause pain syndromes or loss
of motor control at extremities (arms and legs). When a motor nerve
is pinched, the patient experiences weak muscle response or even
loss of motor control of the affected arm/leg. When a sensory nerve
is pinched, the patient experiences tingling sensation, numbness in
certain areas of the affected arm or leg. Herniated discs are often
cited as the cause of the problem in radiological interpretation of
CT scans. However, it is misleading because (1) most herniated
discs do not even touch the nearby nerve and thus not necessarily
cause any pain, and (2) herniated discs occur even in normal people
with no pain or known injury. Most pinched nerve problems, as our
clinical study indicates, are actually caused by injuries of the
muscle groups that support and balance the spine. When the injuries
of those corresponding muscles, mostly near the neck or the lower
back, are healed, the pinched nerve problem and any associated pain
disappear as well.
[0005] Standard treatments for chronic pain typically include
physical therapy, pain medication, epidural injection of steroids,
and surgeries. The treatment process is long and ineffective:
Majority of the patients had little or no improvement after six
months or longer of various therapies. The epidural injection is
useful to reduce neural inflammation. However, most of the chronics
pains described above are not neural inflammation. Thus, majority
of patients either experience no improvement or temporary
improvement with a rebound in a few days or few months when the
epidural steroid wears off. In addition, due to the serious
side-effect of steroids, epidural injection can only be used for
several times. The prognosis of surgery was even less positive.
Most of patients who undergo such invasive surgeries on and after
six-month recovery periods found that their conditions are not
better or even worse than before the surgery. Pain medications,
including both prescription anti-inflammatory drugs and
over-the-counter analgesic medicine, are often used to relieve the
pain temporarily and reduce the inflammation hoping that the body
will heal the injury itself once inflammation is reduced. For some
patients with acute injury, the pain medication will bridge them
through the recovery process with less or no pain. Unfortunately,
chronic pain patients usually experience temporary relief with
medications. The pain returns within hours after medication is
taken. In essence, majority of people who have chronic pain would
go through multiple years of treatments without a permanent
cure.
[0006] Based on extensive medical and biological research, when
deep (muscle) tissues are injured, it triggers a cascade of the
healing process mediated by innate immune system: The injured
muscle/soft tissue triggers the release of cytokines (chemicals
carry signals to promote or inhibit immune responses), which
recruit the innate immune cells (e.g., macrophages) to take away
the dead and injured tissue cells. Macrophages in turn release
other cytokines (e.g., IGF-1) and trigger the cascade of the muscle
tissue repair and regeneration. In normal cases, the immune system
eventually heals the muscle. Unfortunately, the process often gets
interrupted and never completes. Interruptive processes include:
[0007] Scar tissue formation
(b-FGF.fwdarw.fibroblast.fwdarw.fibrosis.fwdarw.scars) [0008]
Excessive and prolonged inflammation [0009] Sheared muscle
(structural damage of the connective tissue/framework) [0010] Age
effect [0011] Cycle aborted due to various environmental
influences
[0012] When interrupted, the patient is stuck with the chronic pain
and injury.
SUMMARY
[0013] The clinical study conducted in the application firmly
implicates that nociceptors (i.e., pain receptors) of the muscle
sensory nerve (esp., the C-fiber) participate (respond) in the
healing process and ensure the positive signaling to the healing
process and that the specific threshold-gated electrical
stimulation procedure described in this application triggers the
neural signaling and thus the healing process on the immune system
side, based on the thousands of cases in which muscle
injuries/pains recovered within a few hours to a few days after the
procedure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] One or more embodiments of the present invention are
illustrated by way of example and not limitation in the figures of
the accompanying drawings, in which like references indicate
similar elements.
[0015] FIG. 1 illustrates a 59 year old patient injured his back
after trying to pick up a heavy box. Couldn't bend more than 20
degrees. Had lower back pain.
[0016] FIG. 2 illustrates locating muscle group(s) responsible for
the pain of the example patient.
[0017] FIG. 3 illustrates an example of locating a "Nocipoint."
[0018] FIG. 4 illustrates tracing anatomically to find the second
Nocipoint.
[0019] FIG. 5 illustrates an example case repeating the procedure
on other pairs of Nocipoints.
[0020] FIG. 6 illustrates within 25 minutes, the patient recovered
after the first treatment with full motion range. No more back pain
since then.
[0021] FIG. 7 is a chart illustrating relative pain levels BEFORE
and AFTER the Nocipoint Therapy.
[0022] FIG. 8 illustrates a patient before treatment.
[0023] FIG. 9 illustrates the patient after treatment.
DETAILED DESCRIPTION
Nocipoint Stimulation Therapy--A Threshold-gated Electrical
Neuro-Immuno-Stimulation:
[0024] The Nocipoint Stimulation Therapy is a process using
electrical stimulation in a precise manner that activates the
complete healing of (1) muscle injury with associated local pain,
and (2) muscle injury that causes pinched nerve and indirectly
causes remote pains and/or loss of motor control at the extremities
(legs, arms) in a short time:
Steps:
[0025] (1) The patient identifies the general area of the pain:
(e.g., the left shoulder/the lower left back)
[0026] (2) Decide whether the pain is caused by the muscle(s)
locally or a pinched nerve at the spinal cord remotely. In the
latter case, find the muscle groups that structurally support the
vertebrae near the pinched nerve. A few tests are well documented
in clinical diagnosis to differentiate local muscle pain from
pain/muscle weakness caused by pinched nerve. To name a few: [0027]
a. Injury history: If someone springs his/her ankle, the ankle pain
is most likely caused by local injury. [0028] b. The local pains
are usually associated with certain movement and will always
present when the same movement is performed. [0029] c. The pain
caused by pinched nerve often can be temporarily relieved by
changing the patient's posture s or via spinal traction. These
maneuvers can be used to differentiate the pinched nerve problems
from local muscle injuries. However, the pain will come back soon
afterward.
[0030] See FIG. 1. Example: A 59 year old patient injured his back
after trying to pick up a heavy box. Couldn't bend more than 20
degrees. Had lower back pain.
[0031] (3) Use the human anatomy to locate the muscle(s) that is
likely to be responsible for the identified pain area above. This
research has found that the anatomical layout of each muscle and
its expected kinetics is critical in identifying the muscle. A 3-D
anatomy model will be useful for this.
[0032] See FIG. 2. Locate muscle group(s) responsible for the
pain
[0033] (4) Find the first "Nocipoint": Based on the candidate
muscle group(s) identified above, press at or near one of the
insertion points of the muscle(s), and find the "Nocipoint". This
research has discovered that a "Nocipoint" is a small area located
at the end of an injured muscle and is painful only when
pressed/touched. These Nocipoints are very sensitive to even light
presses, but patients usefully did not feel any pain there if not
so touched. The patient will experience sharp pain when the
Nocipoint is touched. Anatomically, they are where the nociceptors
of the muscular sensory nerve (i.e., the free nerve ending)
are.
[0034] See FIG. 3. Example: Locate a "Nocipoint"
[0035] (5) Find the second matching "Nocipoint" by tracing the
muscle in anatomy map: For each muscular injury/pain, one will
ALWAYS find another "Nocipoint" near another insertion point at the
other end of the muscle. Certain muscle groups with more than two
insertion points will have multiple corresponding Nocipoints.
Patients are often surprised by the presence of these touch-induced
pain points. Sometimes one of the Nocipoints is far away from the
perceived painful area. Thus, following the muscle anatomically is
critical to precisely locate the matching Nocipoints. Note that,
while there may be more than two insertion points/ends of a muscle
group (e.g., triceps), there are always exactly two ends of at the
muscle fiber level, and thus two Nocipoints per muscle fiber.
[0036] See FIG. 4. Trace anatomically to find the second
Nocipoint
[0037] The Nocipoints described here always come in pairs. No prior
art has ever figured out that it requires a PAIR of the matching
painful points per muscle group to induce the injury curing
process.
[0038] The complexity comes in when multiple groups of muscles in
the same area are injured. In such cases, multiple Nocipoints
(sometimes as many as 4-6 points) may express in the nearby area
and should be paired respectively based on the muscle anatomy.
[0039] (6) Nocipoint Stimulation Therapy:: In order to trigger the
responses of the C-fiber nerve nociceptors, the electrical
stimulation at the neuron needs to fall within a narrow range of in
order to activating the neuro-immuno cascade and gain the optimal
curing effect. The signaling process of the sensory nerve has the
following thresholds subcutaneously: [0040] a. The firing threshold
(when the depolarization of the neuron cell starts): 10mV [0041] b.
The action potential (when the depolarization ends and
repolarization of the neuron cell starts): 60mV
[0042] Based on the biofeedback of the patients in this study, it
is evident that the electrical stimulation needs to be between the
two thresholds to have curing effect. However, due to the high
resistance (700 K to 1.3 M Ohm), the stimulating pulse at the skin
surface degrades quickly before it reaches the free nerve ending of
the nocireceptor. It needs to be at much higher voltage/amplitude
than what is measured at the axon of the neuron. Some clinical
examples of the operating stimulations at skin surface (i.e.,
transcutaneous electrical nerve stimulation, TENS) are as
follows:
TABLE-US-00001 Pulse Operating range of Wave pattern frequency
pulse amplitude Square wave/Sine wave 9 Hz 130 V-170 V Square wave
20 Hz 70 V-95 V
[0043] Note that the two transcutaneous stimulation patterns above
match with the known behaviors of the spatial and temporal
summation of the action potential at the sensory nerves, and
typically needs a train of impulses. While the first pulse pattern
has higher amplitude range, recruiting enough nerve endings to
propagate the pain-signal; the second pattern works just as
effective with a faster pulse (20 Hz vs. 8Hz) yet lower
amplitudes.
[0044] Given that every person varies in age and sensitivity to
pain, minor adjustments are sometimes needed: Further adjust the
strength/frequency/wave pattern above the "firing potential" and
within the "depolarization" range of the nociceptor. In certain
embodiments, the working frequency range can be as high as about 70
Hz.
[0045] A simple biofeedback can be used to "calibrate" the
stimulation setting: when the patient starts to feel a sensation of
deep pressure (i.e., when C fibers of the sensory nerve are
triggered), but not a muscle spasm or sharper pain, the nociceptor
is by definition above the firing potential and below the action
potential thresholds. It is known that the C-fiber transmits "dull
pain" or "soreness" signals (instead of the sharp pain). Thus, the
patient-provided biofeedback of feeling the dull pain confirms that
the electrical stimulation is within the above thresholds. That is
the operating range of the Nocipoint stimulation.
[0046] Note that all values above and below are approximate.
[0047] (7) For each pair of Nocipoints, carefully control the
stimulation duration within a tight range between 1.5 minutes to
3.5 minutes. Minor variance is alright based on age and muscle
tone, but excessive long time (e.g., >8 minutes) does not
necessarily yield the best healing result. In fact, it may be
counterproductive, as the clinical study revealed.
[0048] (8) Repeat the process on other muscle if necessary: If the
correct pair of Nocipoints is stimulated, the patient will
experience instant relief of pain of the stimulated muscle. And
within a few minutes, the muscular function will be restored.
Typically, however, multiple muscle injuries collectively cause the
pain. Thus, repeat the same process to all other pairs of the
Nocipoints.
[0049] See FIG. 5. Example case: Repeat the procedure on other
pairs of Nocipoints
[0050] (9) When all pairs of Nocipoints for the injured muscle
groups are identified anatomically and stimulated, the process is
complete. All pains will be relieved and patient will be able to
regain all functions. Typically, it will be completed within 2-8
hours in 1-5 sessions.
[0051] See FIG. 6. Within 25 minutes, the patient recovered after
the first treatment with full motion range. No more back pain since
then.
[0052] (10) Waiting period: Immediately after the treatment is
complete, the patient should go easy on the just-recovered muscles.
Though these muscles are healed, the fibers may not be strong
enough yet. To prevent new injury to the same muscle, wait for a
few days. For people who are aged or weak muscles, avoid extraneous
uses for at least about one week. For young people or strong muscle
tone, about 2-4 days of waiting are advised. During the waiting
period, some light exercise can be performed to train the newly
healed muscles.
Control Study
[0053] 1. Patient Profiles: [0054] (a) Pain/tingling sensation at
extremities or loss of motor control due to pinched nerves, which
may or may not be present all the time. Most of them had functional
deficiencies. Ages: 35-65 [0055] (b) Chronic neck pain and back
pain for various (sometimes unknown) reasons, having lasted 2-20
years. All had tried many treatment protocols (physical therapy,
epidural injection, acupuncture, massage, etc.) without notable
improvement. Many were also on prescribed analgesics. Patients'
ages are between 30 and 79. [0056] (c) Lingering pain at
extremities due to sports injuries, car accidents, or sudden
movements. Many were functionally impaired for over 3 months (some
multiple years). The age group: 15-68 [0057] (a) and (b) groups
often had multiple areas of pain while Group (c) often had
localized pain. Most of them experienced functional constraints of
their arms, legs or the back. Many had symptoms from both tissue
injury and pinched nerve. They were classified in either (a) or (b)
for convenience. Many felt depressed, some showed allodynia or
hyperalgersia. In general, these patients were all stuck with
chronic pains and impaired muscular functions for a long time.
The Treatment Procedure:
[0058] The patients were given the Nocipoint Therapy: Electrically
stimulate certain stimulation points that were anatomically
relevant to injured tissues/sites with controlled timing, strength,
dosing, etc. Because most patients had multiple problem areas, each
session typically lasted for 1.5 hours.
[0059] The results (based on a study of 64 chronic pain
patients):
[0060] 100% patients recovered with full range of motion and only
less than 10% reports Level 1 or 2 out of 10 remaining pain. 89% of
patients recovered in 1-4 sessions. Full recovery is defined as (1)
gaining full range of motion (age appropriate) and (2) persisting
function for at least one month without recurring pains.
TABLE-US-00002 Recovered in # of Remaining pain (.times./10) level
sessions # of patients percentage when treatment stopped 1 7 10.9%
0-1 2 16 25.0% 0-not noticable 3 19 29.7% 0-not noticable 4 15
23.4% not noticable-1 5+ 7 10.9% 1-2 ** 64 total
[0061] Most patients experienced substantial or complete recovery
of muscle function in the first one or two treatments. Later
sessions were typically dealing with secondary/other pains that
were not in the patients' chief complaint initially. (That is, when
the primary problem is cured, the patient's perception starts to
notice secondary and other pains.)
[0062] Arm and hand pains typically involve more muscle groups and
often take longer time than neck/lower back pains.
[0063] ** People who had extensive tissue damages required multiple
sessions/more time to cover all the damaged tissues/muscle groups.
Some patients who went through 4 or 5+ sessions stopped coming
because they were happy with the substantial improvements.
Control-Test Analysis
[0064] Chronic pain patients typically have persistent pain for
months or years, with other conventional treatment/therapy (See
FIG. 1). The patients who received the Nocipoint Therapy
experienced substantial pain relief and regained function
immediately after the treatment. Unlike all prior arts, the
recovery persisted. The control in this study is the historical
pain level before the treatment, while the test is the pain level
afterward the treatment (in the AFTER scenario).
[0065] See FIG. 7. Relative pain levels BEFORE and AFTER the
Nocipoint Therapy
[0066] In order to have a meaningful aggregation across all
patients, the pain levels are normalized at the time right before
the treatment. That is, they are defined as relative pain compared
to the pain level right before the Nocipoint Therapy. Chronic pain
patients typically have persistent pain for months or years, with
or without conventional treatment/therapy, as indicated in the
BEFORE scenario. Patients who received the Nocipoint Therapy
experienced substantial pain relief and regained function soon
after the treatment (the AFTER scenario). Notice that the recovery
persisted afterward. (Note: history earlier than 84 days before the
treatment were ignored in this chart.)
Observations:
[0067] All treatments were done within one to several hours
accumulatively, spreading over one or a few sessions. The gap
between sessions has minor impact on recovery, positive or
negative. That is, patients technically can complete all sessions
consecutively in a short period.
[0068] Patients usually experienced immediate improvement/cure when
the correct Nocipoints are stimulated. This contrasts the 1-2 years
of standard pain management protocol. The Nocipoint Therapy is
precise, reproducible, and with near-perfect success rate.
[0069] Elimination of the placebo effect: During a session, if the
points for stimulation were off by a little from the intended
points mistakenly (e.g., by 1/2 inch), or by a lot intentionally,
the patient could tell and would instantly indicate the lack of
improvement. Correcting the stimulation location to the right
Nocipoints will enable instant result.
[0070] After each session, the patients were instructed to go easy
on exercises with the newly recovered muscles for a few days or a
week for seniors, to prevent new injuries before the tissue gains
enough strength.
[0071] In sum, the procedure cures pains permanently and
persistently. More importantly, it heals injured tissues and
restores functions. It is repeatable and the same results occur in
nearly all cases.
[0072] A recent example: (with patient's permission):
[0073] The patient is 59, who injured his lower back a week before
the treatment while picking up a heavy box. Had been in pain and
had to roll off the bed every day. Worn waist support all days to
avoid pain.
[0074] Before the treatment: See FIG. 8: the maximum angle he could
bend without waist support)
[0075] After a 25-minute treatment: Full range of motion recovered.
No pain since. See FIG. 9.
[0076] Note that any and all of the embodiments described above can
be combined with each other, except to the extent that it may be
stated otherwise above or to the extent that any such embodiments
might be mutually exclusive in function and/or structure.
[0077] Although the present invention has been described with
reference to specific exemplary embodiments, it will be recognized
that the invention is not limited to the embodiments described, but
can be practiced with modification and alteration within the spirit
and scope of the appended claims. Accordingly, the specification
and drawings are to be regarded in an illustrative sense rather
than a restrictive sense.
* * * * *